Faster Access to Cheaper Generic Drugs: Market Exclusivity Changes.
This Act aims to accelerate the market entry of lower-cost generic drugs by modifying rules regarding market exclusivity. It allows for quicker approval of subsequent generic versions if the first applicant delays commercial marketing or if the approval process is prolonged. These changes are intended to boost competition, potentially leading to lower drug prices for consumers.
Key points
Allows the FDA to approve subsequent generic drugs even if the first applicant holds exclusivity, provided the approval process has lasted at least 33 months.
Requires generic manufacturers receiving early approval to begin commercial marketing within 75 days, or their effective approval status will be revoked.
Increases transparency: The FDA must disclose to generic applicants whether their ingredients are qualitatively and quantitatively the same as the original drug, speeding up the approval process.
Expired
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